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Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806]...

FDA Device Recall #Z-2017-2025 — Class II — May 8, 2025

Recall Summary

Recall Number Z-2017-2025
Classification Class II — Moderate risk
Date Initiated May 8, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CareFusion 303, Inc.
Location San Diego, CA
Product Type Devices
Quantity 6,332

Product Description

Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (Main) 10885403512667 [323], MD BD Pyxis SupplyStation V9 [317], Security Module [139698-01], BD Knowledge Portal for Medication Technologies [136607-01], STOCKSTN V10.X WRD/WL SCANNERS [132-53-02], PRS STOCKSTN V10.X WRD/WL SCANNERS [132-53-01], STOCKSTN V10.X WIRED SCANNER [132-52-02], PRS STOCKSTN V10.X WIRED SCANNER [132-52-01], BD Pyxis CII Safe ES Desktop PC [1156-00], BD Pyxis SupplyStation Panel PC V11 [1132-00], BD Pyxis SupplyRoller V11 [1127-00], Dell 640 Server [1128-00], BD Pyxis SupplyStation System V11 [1123-00], BD Pyxis CII Safe ES 10885403512605 [1116-00], BD Pyxis Enterprise Server 10885403518348, 10885403520341 [1115-00], BD Pyxis SupplyRoller V10 [1101-00], BD Pyxis CIISafe V9.X SGL IM BIO 10885403512520 [111-221], BD Pyxis CIISafe V7.X DBL INTG MAIN BIO, SOLID DO [111-194], BD Pyxis CIISafe V8.X Desktop PC, Bio [107-245-01], BD Pyxis SupplyStation V10 [347], BD Pyxis CII Safe V9.X DESKTOP PC [107-252-01], BD Pyxis CII Safe V7.X DBL INTG MAIN BIO CLEAR DO [111-191], BD Pyxis CII Safe V7.XSGL INTG MAIN BIO SOLID DO [111-198], BD Pyxis CII SafeV8.XDBL INTG MAIN BIO SOLID DO [111-202-01], BD Pyxis CII SafeV8.XSGL INTG MAIN BIO SOLID DO [111-206-01], BD Pyxis CII Safe V9.X DBL IM BIO SLD DOORS [111-215], BD Pyxis CII Safe V9.X SGL IM BIO CLR DOORS [111-216], BD Pyxis CII Safe V9.X DBL IM BIO CLR DOORS [111-219], Supply itParActive RF V11 (Supply Kanban) [138566-01]

Reason for Recall

During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of PR, DE, GU, MO, IA, IL, CA, MD, MA, VA, PA, NY, WA, NJ, AZ, CO, OH, FL, WI, TX, CT, LA, MI, WY, MN, AR, KY, OR, NM, TN, NC, SC, IN, VT, KS, AL, GA, WV, NV, ID, DC, MS, NE, HI, OK, UT, ND, MT, NH, SD, ME, RI, AK, MP and the countries of SA, CA, NZ , CH, FR, IT, BE, AU, BH, QA, AE, GB, EG, AR, JO, DE, BM, TH, LB, BR, IE, FI, MX, TW, ID, SG, BS, IN, MA, GF, ES, HK.

Lot / Code Information

Each customer was provided a unique list of their affected devices that included computer names and atlas keys. Distributed: April 14, 2014 - March 21, 2025 REF or Name [UDI-DI]: Supply Server [N/A], CCE Enterprise SW Site License (2-5) [N/A], 806 [N/A], 303 [10885403512629], 352 [10885403512674], 327 [10885403477836], 323 [10885403512667], 317 [N/A], 139698-01 [N/A], 136607-01 [N/A], 132-53-02 [N/A], 132-53-01 [N/A], 132-52-02 [N/A], 132-52-01[N/A] , 1156-00 [N/A], 1132-00 [N/A], 1127-0 [N/A], 1128-00 [N/A], 1123-00 [N/A], 1116-00 [N/A], 1115-00 [10885403518348, 10885403520341], 1101-00 [N/A], 111-221 [10885403512520], 111-194 [N/A], 107-245-01 [N/A], 347[N/A], 107-252-01 [N/A], 111-191 [N/A], 111-198 [N/A], 111-202-01 [N/A], 111-206-01 [N/A], 111-215 [10885403512520], 111-216 [10885403512520], 111-219 [10885403512520], 138566-01 [N/A]

Other Recalls from CareFusion 303, Inc.

Recall # Classification Product Date
Z-1028-2026 Class II BD Pyxis ES Enterprise Server Catalog Numbers 1... Dec 3, 2025
Z-0962-2026 Class II BD Pyxis MedStation ES, REF: 323, BD Pyxis M... Nov 20, 2025
Z-1217-2026 Class II BD Alaris" Pump Module model 8100 UDI-DI code:... Nov 6, 2025
Z-0430-2026 Class I BD Alaris infusion Pump Module 8100, REF: 8100;... Oct 17, 2025
Z-0370-2026 Class II BD Pyxis Pro MedStation Main, REF: 1155-00 Sep 30, 2025

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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